Validación de método Analítico de cuantificación de Pregabalina 150mg cápsulas, por cromatografía de alta resolución (HPLC) en Laboratorio Farmacéutico QUALIPHARM.

Abstract

The aim of the investigation is, to validate the analytical method of quantification of Pregabalin 150 mg capsules in the Pharmaceutical Laboratory Qualipharm, by means of HPLC, in order to verify the quality with regard to dose of the active principle. The analysis was carried out using the high-performance liquid chromatography in reversed phase. The separation and quantification were achieved in column Phenomenex C18 filled with hypersil silica with a ODS 250x60mmx 5µ using the mobile phase consisted of a mixture of Potassium Phosphate, Dibasic, Anhydrous( pH 6.9) and acetonitrile (95:5) (v/v), detection to 200nm at a flow rate of 1ml/min. The separation was achieved within 8.5 ± 0,3 min for the simple of pregabalin. Peak Width was found to a standard deviation of 50.83 and the peak area of the simple is 468873.91. The developed method is linear in the selected concentration range that is 0,5 mg/ml with a correlation coefficient bigger tan 0.99, with a result of 0.997. It is exact because the acceptance criterion is of ≥ 3% of CV the obtained value is a 13.35 % and recovery goes from 95% to 105 %, the obtained result is a 96.69%. It is robust because it is not sensitive to small changes, stable in 24h at room and cooling temperature. The method is accurate because the CV does not exceed 1%. In conclusion the analytical method of quantification for the Pregabalin 150 mg capsules developed by the Pharmaceutical Laboratory Qualipharm mas validated. Consequently its application is recommended to ensure the quality of its medicinal products.